Herceptin

Medical breakthroughs are rare, but the new breast cancer drug trastuzumab (Herceptin) was launched yesterday with all the buzz words we associate with a genuine breakthrough: "magic bullet," "Holy Grail of cancer treatment," "fast-tracked by US licensing authorities," and, best of all, "free of side effects." Even the cancer it treats has a high media profile.

When a public relations company asked me to a press briefing in Milan to hear about this new drug, I hesitated. As a journalist, it is my job to search out news, and the launch of any drug that targets tumour cells while leaving healthy cells unscathed must surely be important. I also know how hungry patients are for any good news at all; as a former cancer patient I am anxious not to build up false hopes, but nor do I wish to withhold valuable information. The real question is, should you tell people about a drug that they probably can't have?

Public relations companies provide vast amounts of information about new drugs, but they don't tell you the cost unless you make a point of asking. A 34 week course of trastuzumab costs 12 000 [pounds sterling], but this is just the starting price. Most of the evidence for its effectiveness comes from trials that combine it with other high cost drugs, such as the taxanes. What all this means is that women who ask for trastuzumab are likely to be refused unless they can be enrolled in a research trial or they have a very understanding private insurer.

Trastuzumab is designed for patients with oestrogen receptor negative cancer, who tend to be younger and have more aggressive forms of the disease that do not respond to standard chemotherapy. They represent about one in four of all patients with breast cancer and are usually aged under 50. This risk group expresses abnormally high levels of a growth factor known as HER2, which can be identified by a newly developed test. Trastuzumab is a monoclonal antibody that binds to the HER2 cell surface receptor, blocking the action of the growth factor.

The existence of a test, however, raises a new problem. How should doctors who have limited or no access to the drug respond to requests for the test? And if the drug is considered (as it inevitably will be) and passed (as it might be) by the National Institute for Clinical Excellence (NICE), how will health authorities pay for it?

It was with these uneasy thoughts that I found myself sitting in a conference room in a Milan hotel, along with other European journalists and representatives of British cancer charities such as BACUP and Breakthrough Breast Cancer. All of our air fares, meals, and hotel bills had been paid for by Roche, manufacturer of the new drug.

I was under no obligation to write anything. So would it be kinder and more ethical for journalists to leave such stories unreported? "Certainly not," said Susan Knox, a campaigner from a European patient pressure group, Europa Donna. "Women with breast cancer need to know what is happening out there. Keep breast cancer on the political agenda. Demand minimum standards for diagnosis and treatment."

Dr Paul Ellis, a consultant oncologist at Guy's Hospital, London, also thought that the story should be told. "This is the first targeted treatment for breast cancer," he said, "which has real clinical benefits for the patients we see every day in the clinic. It represents a whole new era of cancer care, and for me that is truly exciting."

Dr Ellis was paid an honorarium of $1000 by the makers or trastuzumab to go to Milan, but said "I was certainly not there as a hired hand for the drug company."

The honorarium, he said, was "normal practice for any clinician attending such a meeting, and takes into account our time away from our families and the overnight stay."

Did Dr Ellis not feel that he should remain free of drug company ties? "If you do good research, companies come to you with products and as a clinician you have to ask if it is likely to be any good, and of any help to your patients."

He believes that "Herceptin is a good drug which works in a different way and it will stand on its own evidence." He added, "I talk to patients in terms of the drug buying them chunks of life. We have a 33 year old patient with two young children whose cancer had spread to her liver. She was very ill when she started treatment. Six months later, she is well and playing tennis and picking her kids up from school."

Anecdotes like this play out well in the media. But doctors and the public speak a different language. For a doctor, a "good response" is a 50% reduction in tumour size; for the public, and many members of the media, it means a cure.

Inevitably, all the early work on trastuzumab has been carried out on women with advanced disease. Its effects on women with newly diagnosed, HER2 positive cancer that has not yet spread are soon to be tested in a major research trial. As yet, no one knows if the drug will prevent their disease from returning. Success would represent a real breakthrough.

So how should we view the new agent while we wait to discover if it has curative potential? The high cost versus low yield arguments were used against the taxanes. In the end the NICE committee declared that these drugs do work and should be available for the treatment of advanced breast cancer. But official approval does not equate with more money in the budget, and clinicians are likely to be faced with more difficult decisions with the launch of trastuzumab.

Cancer drugs that are effective for carefully selected individuals, but which are extremely expensive, can put a terrible pressure on patients and their families if they have to pay for them out of their own pockets. Some go deeply into debt, while others remortgage their homes.

"Do you think you've got a story?" asks the public relations man anxiously. "Is this a story?" I ask myself. Of course it is, but it is too complex to be told in soundbites. Tailor made cancer drugs are just what patients need. Eventually, the next magic bullet will come along, and, hey-presto, trastuzumab will get cheaper. Health authorities will decide that they can indeed pay for it after all. When they do we might be able to call it a breakthrough. In the meantime it is just a chink of light showing through the door.

Anne Kent health writer, Stowmarket, Suffolk

COPYRIGHT 2000 British Medical Association
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